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Calibrators and standards (clinical chemistry)
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Calibrators and standards (clinical chemistry) - other
Calibrators and standards (clinical chemistry) - other
W0101050399
189 devices
β2-Microglobulin (β2-MG) Calibrator
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Clinical Chemistry Calibrator
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Mission Control
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
Mission complete kit
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
Fluid pack
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
Deprotenizer/Kondycjoner
Przedsiębiorstwo Produkcji i Handlu MEDRIV Sp. z o.o.
·
,
Poland
IVD General
CE/IVDD
Buffer pack
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
Standard solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
β2-Microglobulin (β2-MG) Calibrator
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Access CK-MB Calibrators
Beckman Coulter, Inc.
·
,
United States
Class C
FDA 510(k)
K234005
Active
Cleared 16 Feb 2024
CE/IVDR
+1
authorizations
ISE calibrator
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
Calibrator solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
Clinical Chemistry Calibrator
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Neonatal Phenylalanine Controls
Labsystems Diagnostics Oy
·
,
Finland
IVD Annex II List B
CE/IVDD
Calibrator solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
UF-Calibrator
Sysmex Corporation
·
,
Japan
IVD General
CE/IVDD
System Calibrator
Beckman Coulter Ireland Inc.
·
,
Ireland
Class C
FDA 510(k)
K141388
Active
Cleared 11 Jul 2014
CE/IVDR
+1
authorizations
Rheumatoid Factor (RF) Calibrator
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Standard solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
Selectivity check
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
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